ROI-C MC1445PRecalls & reported problems
LDR Spine Usa, Inc. · ROI-C lordotic implant H9mm 12 x 14mm · Class 2
All models of ROI-C (39)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662663016568), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Fracture
IT WAS REPORTED THAT AN ROI-C IMPLANT FRACTURED DURING INSERTION OF THE PLATE DURING AN EXTENSION SURGERY, BUT THAT THERE WAS NO PATIENT OR PROCEDURAL IMPACT AND A DIFFERENT SIZED IMPLANT WAS AVAILABLE FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955940 ↗
Other Intervertebral Fusion Device With Integrated Fixation, Cervical devices
- NA 03.617.902Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical103 reports
- NA 03.617.900Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical77 reports
- Divergence® Anterior Cervical Fusion System G6626525Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical75 reports
- Divergence® Anterior Cervical Fusion System G6626526Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical49 reports
- NA 03.617.905Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical29 reports
- NA 03.617.904Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical27 reports
- Divergence® Anterior Cervical Fusion System G6626746Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with integrated fixation, cervical21 reports
- NA 03.647.972Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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